Cleaning Device for Catheter and Catheter Including the Same

ABSTRACT

A cleaning device for cleaning a catheter lumen of a tissue removal catheter has a flushing chamber with distal and proximal seals and an inlet port. The proximal seal is a duckbill seal that includes a pair of opposing duckbill members that slidingly accept the distal end portion of a catheter body to form a seal about the catheter body proximal to a proximal opening in of the catheter lumen. Fluid is directed in the inlet port, into the flushing chamber, into proximal opening in the catheter body, and through the catheter lumen to discharge tissue contained in the catheter lumen. In some embodiments, the cleaning device is preloaded on the catheter body. The cleaning device can have an internal stop that engages with an external stop on the catheter body when the cleaning device is positioned in an operative position.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.14/751,288, filed Jun. 26, 2015, the entirety of which is herebyincorporated by reference, and which claims priority to U.S. ProvisionalPatent Application Ser. No. 62/018,049, filed Jun. 27, 2014, theentirety of which is hereby incorporated by reference.

FIELD OF THE DISCLOSURE

Aspects of the present disclosure generally relate to a cleaning devicefor cleaning a catheter.

BACKGROUND OF THE DISCLOSURE

Certain medical devices such as tissue removal catheters requirecleaning to remove collected debris. For example, some tissue removalcatheters include a tissue collection chamber that collects excisedtissue and other debris that is cut away or otherwise extracted from avascular or other biological lumen. When tissue collection chambersbecome full they can be cleaned to empty the collected tissue. Certaincleaning tools have been developed to aid in cleaning the tissuecollection chambers of tissue removal catheters. In one example, acleaning tool is received on the distal tip of an atherectomy catheteruntil it visually appears that the device is in an operative position. Aproximal Touhy Borst seal of the cleaning tool is manually actuated toseal a flushing lumen of the cleaning device about the catheter, andflushing fluid is imparted into the flushing lumen.

SUMMARY OF THE DISCLOSURE

In one aspect a cleaning device for cleaning tissue from a catheterlumen of a tissue removal catheter includes a proximal duckbill sealthat forms a passive fluid seal with the catheter body of the catheter.

In another aspect a catheter includes a preloaded cleaning device. Thecleaning device is slidable from a preloaded position at a proximal endportion of the catheter body to an operative position at a distal endportion of the catheter body.

In another aspect a cleaning device for cleaning tissue from a catheterlumen of a tissue removal catheter includes a one-piece flushing chamberwith interlocking features for securing at least one duckbill seal tothe flushing chamber.

In another aspect a seal for sealing a cleaning device for cleaningtissue from a catheter lumen of a tissue removal catheter around thecatheter includes a sealing skirt configured to sealingly engage aflushing chamber of the cleaning device and be exposed to flushing fluidthat, when pressurized, enhances the sealing engagement between thesealing skirt and flushing chamber.

In another aspect a cleaning device for cleaning tissue from a catheterlumen of a tissue removal catheter includes a flushing chamber withbendable tabs that bend inward to form a retention lip adjacent one endof flushing chamber for securing a seal to the flushing chamber.

Other features will be in part apparent and in part pointed outhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic of a catheter suitable for cleaning with acleaning device;

FIG. 2A is an enlarged view of a distal end portion of the catheterhaving a portion thereof broken away to reveal a catheter lumen;

FIG. 2B is similar to FIG. 2A illustrating the distal end portion of thecatheter in a different configuration;

FIG. 3 is a perspective view of a cleaning device;

FIG. 4 is a section view taken in the plane 4-4 of FIG. 3;

FIG. 5 is a perspective view of a duckbill seal;

FIG. 6 is a section view taken in the plane 6-6 of FIG. 5;

FIG. 7 is a schematic of the cleaning device in a preloaded position onthe catheter;

FIG. 8 is a schematic of the cleaning device in an operative position;

FIG. 9 is a fragmentary partial section view of the cleaning device inthe operative position;

FIG. 10 is section view of another embodiment of a cleaning device;

FIG. 11 is a section view of another embodiment of a cleaning device;

FIG. 12 is a fragmentary exploded side elevation view of anotherembodiment of a cleaning device;

FIG. 13 is a section view of a seal for use with a cleaning device;

FIG. 14 is a fragmentary section of another embodiment of a cleaningdevice; and

FIG. 15 is an end elevation of a flushing chamber of the cleaning deviceof FIG. 14 illustrating tabs of the flushing chamber in a fully bentposition and using broken lines to illustrate the edges of the tabs whenbent outward from the fully bent position to an intermediate position.

Corresponding reference characters indicate corresponding partsthroughout the drawings.

DETAILED DESCRIPTION

Referring to FIG. 1, a catheter is generally indicated at referencenumber 10. The catheter 10 includes an elongate catheter body 12 that issized to be inserted in a biological lumen to extract and remove tissueand other luminal debris. Examples of biological lumens include but arenot limited to an artery, vein, thrombus, etc. The catheter body 12 hasa proximal end portion generally indicated at 14 and a distal endportion generally indicated at 16. A handle adaptor 18 is attached tothe proximal end portion 14. In the illustrated embodiment the handleadaptor is configured to receive a handle (not shown) thereupon. In theillustrated embodiment, the handle and handle adaptor 18 include variousfeatures that can be used to control the catheter 10 in use. Theillustrated catheter 10 is an atherectomy catheter, though it iscontemplated that other types of catheters can also be used withoutdeparting from the scope of the invention. In general, the catheter body12 is configured to be inserted in a biological lumen to remove tissue.In the illustrated embodiment, the distal end portion 14 of the catheterbody 12 is configured to be inserted into an arterial lumen first. Thedistal end portion 16 of the catheter body 12 is configured to extractand remove tissue as described in further detail below.

As shown in FIG. 2A, the distal end portion 16 of the catheter body 12defines a catheter lumen 30 that extends from a proximal opening 32 to adistal opening 34. The catheter lumen 30 is in fluid communication withthe proximal opening 32 and the distal opening 34. In the illustratedembodiment, the proximal opening 32 is a cutter window. A cuttingelement 36 is configured to extend through the cutter window 32 andengage tissue on the wall of the biological lumen. The cutting element36 is configured to rotate at a relatively high speed to slice throughtissue in the biological lumen. The catheter body 12 is configured toslide through the biological lumen in the distal direction as thecutting element 36 rotates. The catheter 10 is configured such thatrotational motion of the cutting element 36 and the translational motionof the catheter body 12 direct cut tissue in the distal direction towardthe catheter lumen 30. Thus, in the illustrated embodiment, the catheterlumen 30 is a tissue collection chamber. In FIG. 2A, the distal opening34 is illustrated covered by a scoop 38. In this configuration the scoop38 is positioned to prevent cut tissue from escaping from the tissuecollection chamber 30 out the distal opening 34. When the tissuecollection chamber 30 is full, the catheter body 12 is configured to bedrawn out of the arterial lumen so the cut tissue can be flushed fromthe tissue collection chamber and discarded. As shown in FIG. 2B, thescoop 38 is configured to be rotated to open the distal opening 34 sothat the tissue contained in the tissue collection chamber 30 can beflushed out through the distal opening. In addition, the cutting element36 is movable relative to the catheter body 12 so it can be drawn intothe cutter window 32, as shown in FIG. 2B.

The distal end portion 16 of the catheter body 12 also includes anexternal stop 40. The external stop 40 is disposed proximal to theproximal opening 32. In the illustrated embodiment, the external stop 40is part of a torque shaft adapter that links a torque shaft of thecatheter 10 to the distal end portion 16. However, in other embodimentsthe external stop can be other components (e.g., a single-purpose stop)without departing from the scope of the invention. As will be discussedin greater detail below, the external stop 40 is configured to engagewith a corresponding feature of a cleaning device to align the cleaningdevice in an operative position in which the cleaning device can flushcut tissue from the tissue collection chamber 30.

Referring to FIG. 3, an embodiment of a cleaning device for cleaning thetissue collection chamber 30 is indicated generally at reference number100. The cleaning device 100 has a generally cylindrical flushingchamber 102 comprising a proximal chamber member 102A and a distalchamber member 102B attached to the proximal chamber member, such as byadhesive, welding, or mechanical fastening. A fluid inlet port 104extends outwardly from a central portion of the flushing chamber 102.The fluid inlet port 104 is configured to fluidly connect to a source offlushing fluid (not shown). For example, in some embodiments, the fluidinlet port 104 can be a luer tip configured to receive a correspondingluer tip of a source of flushing fluid, such as a syringe. It will beunderstood, that other fluid inlet port configurations can also be usedwithout departing from the scope of the invention. The flushing chamber102 has an open proximal end 106 and an open distal end 108. A proximalseal 110 is connected to the open proximal end 106 of the flushingchamber 102, and a distal seal 112 is connected to the open distal end108 of the flushing chamber.

As shown in FIG. 4, the flushing chamber 102 of the cleaning device 100defines a flushing lumen 120. The flushing lumen 120 extends between theproximal and distal ends 106, 108 of the flushing chamber 102, and theinlet port 104 is in fluid communication with the flushing lumen. Fluiddispensed through the inlet port 104 enters the flushing lumen 120. Aswill be explained in further detail below, the flushing lumen 120 isconfigured to accept the distal end portion 16 of the catheter body 12therein through the proximal end thereof. An internal stop 126 issecured to the cleaning device 100 inside the flushing lumen 100. In theillustrated embodiment, the internal stop 126 is a separate componentfrom the flushing chamber 102. It is secured to the chamber 102 with anultraviolet tack bond. However, it should be understood that theinternal stop 126 can be secured within the flushing chamber 120 inother ways without departing from the scope of the invention. Forexample, in some embodiments the internal stop can be integrally formedwith the flushing chamber. As will be discussed in greater detail below,the internal stop 126 is configured, in the illustrated embodiment, toengage with the external stop 40 of the catheter body 12 to align thecleaning device 100 in an operative position with respect to thecatheter body.

Referring still to FIG. 4, the proximal and distal seals 110, 112 areeach secured to a respective end 106, 108 of the chamber 102. Theproximal seal 110 is a duckbill seal that is sealingly received in theflushing lumen 120 at a location proximal to the inlet port 104. In theillustrated embodiment, the proximal duckbill seal 110 is sealinglyreceived in the open proximal end 106 of the flushing chamber 102. Theproximal chamber member 102A includes an annular seal mounting flange orlip 127A that extends radially inward into the interior of the chamberadjacent the proximal end 106. The proximal seal 110 defines a radiallyoutwardly extending flange or shoulder 128 (also shown in FIGS. 5 and 6)that engages the annular seal mounting lip 127A when the proximal sealis sealingly received in the flushing lumen and secured to the chamber102. The engagement between the lip 127A and the shoulder 128 inhibitsthe seal 110 from being discharged proximally out the open proximal end106 of the chamber when the flushing lumen 120 is pressurized withflushing fluid. The distal seal 112 of the illustrated cleaning device100 is also a duckbill seal. The distal duckbill seal 112 is sealinglyreceived in the flushing lumen 120 at a location distal to the inletport 104. In the illustrated embodiment, the distal duckbill seal 112 issealingly received in the open distal end 108 of the flushing chamber102. The distal chamber member 102B includes an annular seal mountingflange or lip 127B that extends radially inward into the interior of thechamber adjacent the distal end 108. The distal seal 112 defines aradially outwardly extending shoulder 129 that engages the annular sealmounting lip 127B when the proximal seal is sealingly received in theflushing lumen and secured to the chamber 102. The engagement betweenthe lip 127B and the shoulder 129 inhibits the seal 110 from beingdischarged proximally out the open proximal end 106 of the chamber whenthe flushing lumen 120 is pressurized with flushing fluid.

In one or more embodiments, the flushing chamber 102 is formed in aninjection molding, casting, or other molding process. In the illustratedembodiment, each of the chamber members 102A, 102B is formed separately.A core pin is used to form the flushing lumen 120 and the seal mountinglip 127A, 127B of each respective chamber member 102A, 102B.

Each of the duckbill seals 110, 112 has a sealing passage 122, 124. Inthe illustrated embodiment, the duckbill seals 110, 112 are secured tothe flushing chamber 102 such that the longitudinal axes of the sealingpassages 122, 124 are aligned. As will be discussed in greater detailbelow, the duckbill seals 110, 112 are configured to receive the distalend portion 16 of the catheter body 12 in the sealing passages 122, 124such that the distal end portion of the catheter body extends throughthe flushing lumen 120 in an operative position. Though the illustratedembodiment uses two duckbill seals for the proximal and distal seals 110and 112, it should be understood that other types of seals can also beused without departing from the scope of the invention.

Referring to FIG. 5, the proximal duckbill seal 110 includes a pair ofopposing duckbill members 130, 132. The opposing duckbill members 130,132 are configured to slidingly accept therebetween the distal endportion 16 of the catheter body 12 to form a fluid seal about thecatheter body proximal to the proximal opening 32 of the catheter body.For example, in some embodiments the duckbill seal 110 forms aliquid-tight seal about the catheter body 112, and in other embodimentsthe duckbill seal forms a hermetic seal about the catheter body 112. Inthe illustrated embodiment, the sealing passage 122 passes between theopposed duckbill members 130, 132. Together, the duckbill members 130,132 form a tapered end 134 of the duckbill seal 110. The tapered end 134of the proximal duckbill seal 110 is configured to be received withinthe open proximal end 106 of the flushing chamber 102. Preferably, anouter surface of the tapered end 134 of the duckbill seal 110compressively engages an inner surface of the fluid chamber 102 tosecure the seal in place with respect to the flushing lumen 120 and sealit therein. An external end 136 of the proximal duckbill seal 110extends radially outward from the wider end of the tapered end 134 todefine a radial shoulder 138. The shoulder 138 is configured to engagean external surface of the open proximal end 106 of the flushing chamber102. In the illustrated embodiment, the proximal duckbill seal 110comprises a one-piece body of elastomeric material. Preferably, theduckbill seal 110 is made from a resilient material. It will beunderstood, however, that other materials and constructions can also beused without departing from the scope of the invention.

As shown in FIG. 6, the sealing passage 122 of the proximal duckbillseal 110 has an open proximal end 140 disposed in the external end 136of the seal. Likewise, the sealing passage 122 of the proximal duckbillseal 110 has an open distal end 142 disposed in the tapered end 134 ofthe proximal duckbill seal. The sealing passage 122 is generally taperedfrom its proximal end 140 to its distal end 142 such that the openproximal end 140 of the passage defines a larger opening than the opendistal end 142. The proximal duckbill seal 110 is configured to form aliquid-tight seal about the catheter body 12 at a sealing band 144 atwhich the sealing passage 122 defines an opening having an equilibriumcross-sectional area that is smaller than a cross-sectional area of thecatheter body 12 received in the proximal duckbill seal when thecleaning device 100 is in the operative position. “Equilibriumcross-sectional area” means the cross-sectional area of the opening whenno force is applied to the duckbill seal 110 that affects thecross-sectional shape of the sealing passage 122. In the illustratedembodiment, the sealing band 144 defines a slit. However, it should beunderstood that sealing bands can also define larger openings withoutdeparting from the scope of the invention. The opening of the sealingband 144 may have a sealing cross-sectional area that compressivelyconforms to the cross-sectional shape of the catheter body 12 that isreceived in the proximal duckbill seal 110 when the cleaning device 100is in the operative position. The resilient material of the proximalduckbill seal 110 suitably forms a fluid-tight interface with the distalend portion 16 of the catheter body 12 when the cleaning device 100 isin the operative position.

The resilient duckbill seal 110 forms a liquid-tight seal with thecatheter body 12 as soon as it is placed in the operative position. Itis a passive seal that requires no additional sealing actuation otherthan the force applied to position the cleaning device 100 in theoperative position. Because the sealing band 144 of the proximalduckbill seal 110 has an opening having an equilibrium cross-sectionalarea that is smaller than the cross-sectional shape of the catheter body12, the resilient material of the seal conforms to the shape of thecatheter body as it slides into the operative position. The compressiveforce of the resilient material is alone enough to create a liquid tightseal with the catheter body 12. Thus, the user of the cleaning device100 only has to perform one step to form a liquid-tight seal with thecatheter body 12 at the proximal end 106 of the flushing chamber 102:slide the cleaning device into the operative position. The duckbill seal110 is axially fixed with respect to the flushing chamber 102. Noportion of the of the duckbill seal 110 moves axially with respect tothe flushing chamber 102 in order to form a liquid-tight seal. Thesefeatures reduce the time and effort required for cleaning the tissuecollection chamber 30 of the catheter body 12 when performing aprocedure such as atherectomy.

In the illustrated embodiment of a cleaning tool 100, the distal seal112 is substantially identical to the proximal duckbill seal 110. Thus,the distal duckbill seal 112 is sealingly received in the flushing lumen120 of the cleaning device 100 at a distal end 108 thereof. The distalduckbill seal 112 includes a pair of opposing duckbill membersconfigured to slidingly accept therebetween the distal end portion 16 ofthe catheter body 12 to form a liquid-tight seal about the catheter bodyproximal to the distal opening 34.

When the distal seal 100 is installed in the flushing chamber 102,however, its sealing passage 124 has a distal opening that is wider thanits proximal opening. Moreover, the distal opening of the sealingpassage 124 is disposed in the external end of the distal duckbill seal112 and the proximal opening of the sealing passage 124 is disposed inthe tapered end. It should be understood that, though substantially thesame components are used for the proximal seal 110 and the distal seal112, different seals can also be used without departing from the scopeof the invention.

Referring to FIG. 7, in one embodiment, the cleaning device 100 ispreloaded on the catheter 10. “Preloaded” means the catheter body 12extends through the flushing lumen 120 of the cleaning device 100 beforethe distal end portion 16 of the catheter body is inserted into abiological lumen. When the cleaning device 100 is preloaded it can bemoved distally from adjacent the proximal end portion 14 of the catheterbody 12 toward the distal end portion 16 of the catheter body toposition the cleaning device in the operative position. In the preloadedposition, the cleaning device 100 is located generally at the proximalend portion 14 of the catheter body 12. The proximal end portion 14 ofthe catheter body extends through the flushing lumen 120 of the cleaningdevice and through the sealing passages 122, 124 of the distal andproximal seals 110, 112 when the cleaning device is in the preloadedposition. From the preloaded position, the cleaning device 100 isconfigured to slide distally along the catheter body 12 until it reachesthe operative position. In the illustrated embodiment, the cleaningdevice 100 cannot slide proximally past the preloaded position. Thehandle adaptor 18 of the catheter 10 is configured to inhibit thecleaning device 100 from sliding further proximally past the preloadedposition. Thus, in the illustrated embodiment, the handle adaptor 18functions as a stop attached to the proximal end portion 14 of thecatheter body 12 and configured to inhibit the cleaning device 100 fromsliding proximally past the preloaded position. More specifically, theexternal end 136 of the proximal duckbill seal 110 is configured toengage the handle adaptor 18 to inhibit the cleaning device 100 fromsliding proximally past the preloaded position. The cleaning device canalso be inhibited from sliding proximally past the preloaded position inother ways without departing from the scope of the invention. As will bediscussed in further detail below, when the cleaning device 100 is inthe preloaded position, the catheter 10 is configured to permit thedistal end portion 16 of the catheter body 12 to be inserted into abiological lumen until it is positioned adjacent tissue to be removed.

The cleaning device 100 is configured to slide from the preloadedposition at the proximal end portion 14 of the catheter body 12 to theoperative position at the distal end portion 16 of the catheter body, asshown in FIG. 8. Thus, in the illustrated embodiment, the cleaningdevice 100 is configured to slide in the proximal-to-distal directiontoward the operative position. Referring to FIG. 9, in the operativeposition, the proximal duckbill seal 110 forms a liquid-tight seal(e.g., at the sealing band 144) about the catheter body 12 proximal tothe proximal opening 32. Likewise, in the operative position, the distalseal 112 forms a liquid-tight seal about the catheter body 12 distal tothe proximal opening 32 and proximal to the distal opening 34. Thus, theproximal opening 32 is disposed between the proximal and distal duckbillseals 110, 112 within the flushing lumen 120, and the distal opening 34is located distal to the distal duckbill seal outside of the flushinglumen. In the illustrated embodiment, the distal seal 112 forms aliquid-tight seal about the catheter body 12 at a location closer to thedistal opening 34 than the proximal opening 32. However, otherarrangements can also be used without departing from the scope of theinvention.

The cleaning device 100 is configured to fluidly connect a fluid sourceto the distal end portion 16 of the catheter body 12 and direct fluidfrom the fluid source into the tissue collection chamber 30 through theproximal and distal openings 32, 34 to facilitate cleaning of the tissuecollection chamber. In the operative position of the illustratedembodiment, the proximal and distal openings 32, 34 form a fluid inletand fluid outlet, respectively, of the tissue collection chamber 30. Thecleaning device 100 is configured to receive fluid that is directed intothe inlet port 104 and that thereby enters the flushing lumen 120. Theproximal and distal duckbill seals 110, 112 are configured to preventthe fluid from escaping the flushing lumen out the open ends 106, 108 ofthe cleaning device 100. In the operative position, the proximal opening32 is disposed between the distal and proximal seals 110, 112 and isconfigured to receive the fluid in the flushing lumen 120 such that thefluid flows through the tissue collection chamber 30 and out the distalopening 34. The pressure of the fluid in the tissue collection chamber30 directs tissue contained therein out the distal opening along withthe fluid.

Though in the illustrated embodiment the proximal opening 32 of thedistal end portion 16 of the catheter body 12 is disposed within theflushing lumen 120 and the distal opening 34 is disposed outside theflushing lumen in the operative position, in other embodiments acleaning device can be arranged differently with respect to a catheterbody in the operative position. For example, in one embodiment, a distalopening of a distal end portion of a catheter body is disposed within aflushing lumen of a cleaning device and a proximal opening of the distalend portion of a catheter body is disposed outside the flushing lumen ofthe cleaning device in the operative position. In this embodiment, thecleaning device is configured for fluid to flow in an inlet of thecleaning device, into the flushing lumen, in the distal opening of thedistal end portion of the catheter body, through a tissue collectionchamber, and out the proximal opening of the distal end portion of thecatheter body.

As illustrated in FIG. 9, in the operative position, the external stop40 of the catheter 10 is engages the internal stop 126 of the cleaningdevice 100 to inhibit the cleaning device from sliding distally past theoperative position. In certain embodiments, the cleaning device 100 isentirely inhibited from sliding distally past the operative position,such that further sliding would cause breakage of one or both of theinternal stop 126 and the external stop 40. In other embodiments, thecleaning device 100 is partially inhibited from sliding distally pastthe operative position, such that, depending on the angular alignment ofthe cleaning device 100 and catheter body 12, the internal stop 126 willengage or fail to engage the external stop 40. In the illustratedembodiment, engagement between the external stop 40 of the catheter body12 and the internal stop 126 of the cleaning device 100 positions thecleaning device in the operative position with respect to the catheterbody. Thus, a user can merely slide the cleaning device 100 from thepreloaded position distally until the internal stop 126 of the cleaningdevice engages the external stop 40 of the catheter body 12 to positionthe cleaning device in the operative position. This greatly simplifiesthe process of flushing the tissue collection chamber 30 of itscontents. The user is no longer required to visually determine properpositioning between the cleaning device 100 and the catheter body 12because the engagement between the internal stop 126 and the externalstop 40 provides an easy-to-identify and precise indication of properpositioning. Positioning errors and flushing procedure time are, thus,greatly reduced.

Though in the illustrated embodiment the cleaning device 100 ispreloaded on the catheter body 12, in other embodiments the cleaningdevice can be unloaded. For example, the cleaning device 100 can have anunloaded position in which the cleaning device is disconnected from thecatheter body 12. In the unloaded position, no portion of the catheterbody 12 is disposed within or extends through the flushing lumen 120 ofthe cleaning device 100. The cleaning device 100 can be configured toslide from the unloaded position disconnected from the catheter body 12to an operative position at the distal end portion 16 of the catheterbody. More specifically, the tip of the distal end portion 16 can beinserted into the proximal opening 140 of the sealing passage 122 of theproximal duckbill seal 110 and the distal end portion of the catheterbody can be inserted through the flushing lumen 120 and sealing passage124 of the distal seal 112 until the cleaning device reaches theoperative position. In this embodiment the cleaning device 100 slidesalong the catheter body 12 toward the operative position in thedistal-to-proximal direction. It is contemplated that, in thisembodiment, an internal stop of the cleaning device could be arranged toengage an external stop of the catheter body when the cleaning device ispositioned in the operative position.

In one embodiment of a method of using the catheter 10, a distal endportion 16 of the catheter body 12 is inserted into an incision andfurther into a biological lumen of a patient (e.g., an artery). Thecatheter body 12 is moved along the biological lumen until the distalend portion 16 is positioned adjacent tissue to be removed. Usingcontrols disposed on the handle adaptor 18 and/or handle (not shown),the cutting element 36 of the catheter 10 is positioned to operativelyengage tissue to be removed. A driver (not shown) of the catheter 10 issubsequently actuated using the controls, which causes the cuttingelement 36 to rotate about its longitudinal axis to slice away thetissue. Simultaneously, the catheter body 12 is inserted distallyfurther into the biological lumen. The excised tissue is directed intothe tissue collection chamber 30 until it is filled. One skilled in theart will appreciate that “filled” does not require the entire volume ofthe tissue collection chamber to be occupied by tissue. Once the tissuecollection chamber 30 is filled, the catheter body 12 is drawn out ofthe biological lumen.

The present embodiment of a method of using the catheter 10 includesperforming the steps of a method of cleaning the collected cut tissuefrom the tissue collection chamber 30. Once the catheter body 12 hasbeen removed from the biological lumen, the cleaning device 100 ispositioned in the operative position with respect to the catheter body12. In one embodiment, the preloaded cleaning device 100 is slid fromits preloaded position (FIG. 7) to its operative position (FIG. 8). Forexample, the preloaded cleaning device 100 is slid distally along thecatheter body 12 until the internal stop 126 of the cleaning deviceengages the external stop 40 of the catheter body 12. In anotherembodiment, an unloaded cleaning device 100 is slid proximally from theunloaded position to the operative position with respect to the catheterbody 12. For example, the tip of the distal end portion 16 of thecatheter body 12 is inserted into the sealing passage 122 of theproximal duckbill seal 110, through the flushing lumen 120, and out thesealing passage 124 of the distal duckbill seal 112.

Once the preloaded cleaning device 100 reaches its operative position,its proximal duckbill seal 110 passively forms a liquid-tight seal withthe distal end portion 16 of the catheter body 12, without anyadditional sealing actuation. Likewise, the distal duckbill seal 112passively forms a liquid-tight seal with the distal end portion 18 ofthe catheter body 12, without any additional sealing actuation. Theproximal duckbill seal 110 compressively conforms to the cross-sectionalshape of the catheter body 12 at the sealing band 144. In the operativeposition, the proximal duckbill seal 110 forms a liquid-tight seal withthe catheter body 12 proximal to the proximal opening 32 of the distalend portion 16 of the catheter body 12. The distal duckbill seal 112forms a liquid-tight seal distal to the proximal opening 32 of thedistal end portion 16 of the catheter body 12 and proximal to the distalopening 34 of the distal end portion of the catheter body. With thecleaning device 100 in the operative position, flushing fluid isimparted through the fluid inlet port 104 and into the flushing lumen120. The flushing fluid at least partially fills the flushing lumen 120and is directed into the tissue collection chamber 30 through theproximal opening 32. The flushing fluid flows through the tissuecollection chamber 30 and out the distal opening 34 of the distal endportion 16 of the catheter body 12. As it flows through and out of thetissue collection chamber 30, the flushing fluid expels tissue containedin the tissue collection chamber 30 out the distal opening 34.

Referring to FIG. 10, another embodiment of a cleaning device isgenerally indicated at reference number 200. The cleaning device 200 issubstantially similar to the flush tool 100, except for the differencesthat are, in part, apparent and, in part, pointed out hereinafter.Features of the cleaning device 200 that correspond with features of thecleaning device 100 are given the same reference number, plus 100. Likethe cleaning device 100, the cleaning device 200 is configured toreceive the catheter body 12 and to direct flushing fluid through thetissue collection chamber 30 to discharge debris from the tissuecollection chamber. Unlike the cleaning device 100, the cleaning device200 includes a one-piece flushing chamber 202. The flushing chamber 202has an open proximal end 206 and an open distal end 208. In a preferredembodiment, the cleaning device is formed in an injection moldingprocess using a single core pin, for example. Whereas the flushingchamber 102 includes two internal annular seal retention lips 127A, 127Bthat extend radially inward adjacent the ends 106, 108 thereof, theflushing chamber 202 includes a proximal external annular seal retentionflange or lip 227A and a distal external annular seal retention flangeor lip 227B that extend radially outwardly adjacent the proximal end 206and distal end 208, respectively.

The cleaning device 200 includes proximal and distal seals 210, 212 thatfunction substantially similar to the seals 110, 112. Each of the seals210, 212 has an internal end 234 that is sealingly received in therespective open end 206, 208 of the flushing chamber 202 and an externalend 236 that protrudes from the flushing chamber. The internal end 234of each of the seals 210, 212 engages the interior surface of theflushing chamber to form a seal interface therewith. Preferably, theinternal ends 234 of the seals 210, 212 are held in compression to forma tight seal with the respective ends 206, 208 of the flushing chamber202. An annular retention formation 228 extends axially inwardly fromthe external end 236 of each of the seals 210, 212 to grip therespective seal retention lip 227A, 227B and thereby secure the seal tothe flushing chamber 127. Each of the retention formations 228 includesan elbow defining an axially outward facing engagement surface 231. Theaxially outward facing engagement surface 231 engages an annular,axially inward facing surface of the respective seal retention lip 227A,227B. The engagement between the engagement surface 231 and theretention lip 227A secures the proximal seal 210 to the flushing chamber202 and inhibits the proximal seal from being removed from the proximalend 206 of the flushing chamber. Likewise, the engagement between theengagement surface 231 and the retention lip 127B secures the distalseal 212 to the distal end 208 of the flushing chamber 202.

Referring to FIG. 11, another embodiment of a cleaning device isindicated generally at reference number 300, The cleaning device 300 issubstantially similar to the cleaning device 200, except for thedifferences that are, in part, apparent and, in part, pointed outhereinafter. Features of the cleaning device 300 that correspond withfeatures of the cleaning device 200 are given the same reference number,plus 100. Like the cleaning device 200, the cleaning device 300 includesa one-piece flushing chamber 302 and proximal and distal seals 310, 312and is configured to direct flushing fluid through the tissue collectionchamber 30 of the catheter body 12. Each of the seals 310, 312 includesan annular retention formation 328 that grips a respective one of theretention lips 327A, 327B to secure the seal to the respective end 306,308 of the flushing chamber 302.

The internal end portions 334 of the seals 310, 312 are configured tosealingly engage the interior of the flushing chamber 302. Moreover, asfluid pressure in the flushing lumen 320 increases, the tightness of theseal interfaces between the seals 310, 312 and the flushing chamber 302also increases. Each of the seals 310, 312 includes an annular sealingskirt 341 that sealingly engages the interior surface of the flushingchamber 302. The sealing skirt 341 surrounds and is spaced radially fromthe opposing duckbill members 330, 332. A generally annular void 345 isdefined between the sealing skirt 341 and the duck bill members 330,332. When each of the seals 310, 312 is installed in the flushingchamber 302, the void 345 is in fluid communication with the flushinglumen 320. When fluid fills the flushing lumen 320, the fluid likewisefills the annular voids 345. A positive pressure urges the generallyaxially extending portions of the skirts 341 radially outward againstthe flushing chamber, thereby enhancing the sealing engagement betweenthe sealing skirts and the flushing chamber. A positive pressure in theannular voids 345 also urges the duck bill members 330, 332 inward toenhance sealing engagement with the catheter body 12 receivedtherebetween. An inner, free end of each of the sealing skirts 341 ischamfered to prevent pressurized fluid in the flushing chamber 320 fromimparting a generally axially oriented force on the end of the sealingskirts that may tend to cause the sealing skirt to buckle and lose itsseal with the flushing chamber 302.

Referring to FIG. 12, another embodiment of a cleaning device isgenerally indicated at reference number 400. Although not illustrated inits entirety, like the cleaning device 200, the cleaning device 400preferably includes a one-piece flushing chamber 402 and proximal anddistal seals (only the proximal seal 410 is shown in Fig. configured toform a seal around portions of the catheter body 12 as the catheter bodyextends through the flushing lumen 420. Unlike the flushing chamber 202,the flushing chamber 402 does not include a seal retention lip. Instead,four slots 451, which are angularly spaced apart around thecircumference of the flushing chamber 402, extend radially through thewall of the flushing chamber adjacent the proximal end 406 thereof. Eachof the four slots 451 adjacent the proximal end 406 of the flushingchamber 402 is configured to receive a respective one of four lugs 453that extends radially outwardly from a stem portion 435 of the internalend portion 434 of the proximal seal 410. The stem portion 435 is sizedto sealingly engage the flushing chamber 402 when the seal 410 isreceived in the open proximal end. The inner axial ends 455 of the lugs453 slope radially inward to enable the seal 410 to be inserted into theopen proximal end 406 of the flushing chamber 402. The lugs 453 of theseal 410 are received in the slots 451 when the seal is secured to theflushing chamber. The lugs 453 engage the flushing chamber 402 withinthe slots 451 to inhibit the seals from being dislodged outwardly fromthe open end 406 of the flushing chamber when the flushing lumen 420 isfilled with a pressurized fluid. Although the illustrated embodimentuses four rectangular shaped slots 451 and four rectangular shaped lugs453, other embodiments can use other numbers and configurations of slotsand lugs without departing from the scope of the invention. The distalend (not shown) of the flushing chamber 402 may also include slots forreceiving a distal seal (not shown) comprising correspondinglypositioned lugs, or the distal end could include another structure forsecuring the distal seal without departing from the scope of theinvention.

Referring to FIG. 13, another embodiment of a seal is generallyindicated at reference number 510. Like the seal 410, the seal 510includes radially outwardly extending lugs 553 configured to be receivedin correspondingly positioned slots in a flushing chamber (e.g., theflushing chamber 402) to secure the seal to the flushing chamber. Butunlike the seal 410, the lugs 553 of the seal 510 extend radiallyoutwardly from an annular sealing skirt 541 that surrounds and is spacedradially from the duck bill members 530, 532. When the seal 510 issecured to the flushing chamber, the sealing skirt 541 sealingly engagesthe interior surface of the flushing chamber. The sealing skirt 541 isconfigured so that the tightness of the sealing engagement with theflushing chamber increases as fluid pressure in the flushing lumenincreases. A generally annular void 545 extends between the skirt 541and the duck bill members 530, 532. When the seal 510 is installed in aflushing chamber, the void 545 is fluidly coupled to the flushing lumen.When fluid fills the flushing lumen, the fluid likewise fills theannular void 545. A positive pressure in the void 545 urges thegenerally axially extending portion of the skirt 541 radially outwardly,thereby enhancing the sealing engagement between the skirt and theflushing chamber. Moreover, since the lugs 553 extend from the skirt541, positive pressure in the flushing lumen also urges the lugsradially outwardly, thereby enhancing the engagement between the lugs553 and the flushing chamber. Although in the illustrated embodiment,the sealing skirt 541 is an annular skirt, it is also contemplated thateach of the lugs 553 could be mounted on a separate flap that contactsthe inner surface of the flushing chamber and is exposed to the flushinglumen so that a positive pressure in the flushing lumen urges the flapoutwardly to improve engagement between the supported lug and therespective slot.

Referring to FIGS. 14-15, another embodiment of a cleaning device isgenerally indicated at reference number 600. The cleaning device 600 issubstantially similar to the cleaning device 100, except for differencesthat are, in part, apparent and, in part, pointed out hereinafter.Features of the cleaning device 600 that correspond with features of thecleaning device 100 are given the same reference number, plus 500. Likethe cleaning device 100, the cleaning device 600 includes a flushingchamber 602 and proximal and distal seals (only the proximal seal 610 isillustrated in FIG. 14) that are respectively secured to the openproximal and distal ends (only the proximal end 606 is illustrated inFIGS. 14 and 15) of the flushing chamber. When the catheter body 12extends through flushing lumen 620 of the cleaning device 600, the seal610 seals around the catheter body to seal the open proximal end 606 ofthe flushing chamber 602. The distal end of the flushing chamber 602could have the same construction as or a different construction than theproximal end 606.

Although the cleaning device 600 preferably functions similar to thecleaning device 100, unlike the flushing chamber 102, the proximal end606 of the flushing chamber 602 includes bendable retention tabs 671 forsecuring the proximal seal 610 to the flushing chamber. In theillustrated embodiment, the proximal end 606 of the flushing chamber 602defines four retention tabs 671 that are spaced around the circumferenceof the flushing chamber wall. In other embodiments, the cleaning devicehas other numbers of bendable retention tabs without departing from thescope of the invention. The retention tabs 671 are bendable from a firstposition (not shown) in which the retention tabs extend substantiallyparallel to the longitudinal axis of the flushing chamber 602 to asecond position (FIGS. 14 and 15) in which the retention tabs extendradially inward toward the center of the flushing chamber. When theretention tabs 671 are bent to the second position, they function like aretention lip for securing the seal 610 to the flushing chamber 602. Inthe illustrated embodiment, the retention tabs 671 are bent inward at anangle of greater than 90° relative to the longitudinal axis of theflushing chamber 602 in the second, bent position. The retention tabs671 may include a zone of weakness (e.g., a recessed portion) along abend line to facilitate bending of the retention tabs at the desiredlocation.

As shown in FIG. 15, each of the retention tabs 671 has a first edge 673and a second edge 675. When the retention tabs 671 are fully bent to thesecond position, the first edge 673 of one tab is separated from theadjacent second edge 675 of another tab by a relatively small gap 677.But as illustrated by the dotted lines in FIG. 15, at an intermediateposition between the first position and second position (e.g., aposition at which the tabs 671 are oriented at about 90° relative to thelongitudinal axis of the flushing chamber 602), an edge margin of eachof the tabs adjacent the first edge 673′ interferes with an edge marginadjacent the second edge 675′ of the adjacent tab. As discussed below,the interference between the tabs 671 at the intermediate positioninhibits the tabs from bending away from the second position when theseal 610 is secured to the proximal end 606 of the flushing chamber 602.

The seal 610 is configured to engage retention tabs 671 bent to thesecond position to secure the seal to the proximal end 606 of theflushing chamber 602. Referring to FIG. 14, the seal 610 includes anannular projection 681 that extends radially outward from the internalend portion 634 of the seal and is configured to sealingly engage theinterior surface of the flushing chamber 602. The annular projection 681and external end portion 636 of the seal define an annular groove 683.When the seal 610 is secured to the flushing chamber 602, each of thetabs 671 is received in the groove 683 in the second position. When theseal 610 is in the proper position, the external end portion 636 of theseal 610 engages an annular stop 691 extending radially outwardly nearthe end 606 of the flushing chamber 602. The tabs 671 engage an axiallyfacing engagement surface 685 of the projections 681 to inhibit the sealfrom sliding outwardly from the end 606 of the flushing chamber 602.Because the tabs 671 are bent to an angle of greater than 90° when inthe second position, the outward axial forces exerted on the seal 610due to positive pressure in the flushing lumen act in compressionagainst the tabs 671, rather than purely to impart a bending moment onthe tabs. It is believed that the tabs 671 are less prone to bendingback toward the first position as a result of compressive forcesimparted thereupon than in response to a bending moment impartedthereupon. If the seal 606 is displaced axially outwardly, all of thetabs 671 are bent away from the second position at the same time, andadjacent edge margins of the each of the tabs interfere with one anotheras the tabs are bent back toward 90° relative to the longitudinal axisof the flushing chamber 602. It is believed that the interferencebetween the edge margins of the tabs inhibits the tabs from bending fromthe second position to and/or past 90°. Thus, the bendable tabs 671 areconfigured to resist bending from the second position toward the firstposition when the seal 610 is secured to the flushing chamber 602.

When introducing elements of the present invention or the preferredembodiment(s) thereof, the articles “a”, “an”, “the” and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

As various changes could be made in the above apparatuses, systems, andmethods without departing from the scope of the invention, it isintended that all matter contained in the above description and shown inthe accompanying drawings shall be interpreted as illustrative and notin a limiting sense.

What is claimed is:
 1. A catheter comprising: a catheter body havingproximal and distal end portions, the distal end portion defining acatheter lumen and proximal and distal openings in fluid communicationwith the catheter lumen; and a preloaded cleaning device received on theproximal end portion of the catheter body and configured to slide from apreloaded position at the proximal end portion of the catheter body toan operative position at the distal end portion of the catheter body,the cleaning device being configured to fluidly connect a fluid sourceto the distal end portion of the catheter body and direct fluid from thefluid source into the catheter lumen through one of the proximal anddistal openings of the distal end portion to facilitate cleaning of thecatheter lumen.
 2. The catheter of claim 1 wherein the catheter body isconfigured to inhibit the cleaning device from sliding distally past theoperative position.
 3. The catheter of claim 2 wherein the catheter bodycomprises an external stop configured to engage an internal stop of thecleaning device to inhibit the cleaning device from sliding distallypast the operative position and to position the cleaning device in theoperative position.
 4. The catheter of claim 1 further comprising a stopdisposed at the proximal end portion of the catheter body and beingconfigured to inhibit the preloaded cleaning device from slidingproximally past the preloaded position.
 5. The catheter of claim 1further comprising a cutter at the distal end portion of the catheterbody, wherein the proximal opening comprises a cutter window throughwhich the cutter is configured to extend.
 6. The catheter of claim 5wherein the distal opening is configured to be selectively closed andopened.
 7. The catheter of claim 5 wherein the instrument lumencomprises a tissue collection chamber configured to receive tissue cutby the cutter.